Evaluation of a New mHealth Tympanometer

NCT05666505 | Completed Results DMC

• 1 other identifier: 274552
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children in rural and underserved communities experience a disproportionately high burden of infection-related hearing loss, which is often preventable with timely identification and follow-up care. A tympanometer is a device that evaluates the health of the middle ear but is often not used in screening programs due to barriers of high cost and need for trained professionals such as audiologists to use the device. To address these barriers, a low cost, lay friendly, mobile health (mHealth) prototype tympanometer has been developed. In addition, a machine learning (ML) algorithm has been designed to guide lay users to interpret tympanometer results, overcoming the need for audiologists. Broad implementation of the lay friendly tympanometer and ML algorithm will transform screening in areas where prevalence of infection-related hearing loss is high, and access to specialty care is limited. In this study the prototype mHealth tympanometer will be evaluated against commercial tympanometry. It will be used by audiologists, an essential step before testing the performance of the device with lay users. Approximately 20 adult patients and 10 pediatric patients with various middle ear pathologies will be enrolled in the study, with the goal of obtaining 60 ears with data from both the prototype and commercial tympanometers. Audiologists will obtain tympanometry measurements on both ears of each participant and interpret the results, first with the prototype device and then with the commercial tympanometer that is typically used during a clinical evaluation. Tympanometry interpretation will include classification into one of 3 categories (Type A, B, or C). Agreement in results between the prototype and commercial devices will be assessed. Agreement between audiologist interpretations and the ML algorithm from the prototype mHealth tympanometer will be assessed.

Conditions

Hearing Loss

Keywords

Rural; Screening; Tympanometer; Mobile health (mHealth); Otitis media; ML Algorithm

Outcome Measures

Primary Outcomes (2)

• Classification Agreement Between Prototype mHealth Tympanometer and Commercial Tympanometer

  Audiologist will test each ear of the participant first with the prototype device, interpret the results into one of the three tympanogram categories (Type A/B/C) and record the results. The procedure will be repeated with a commercial device. Agreement between the two devices with respect to the classification categories will be assessed.

  Same day as participant visit, up to 10 minutes

• Classification Agreement Between Audiologist and ML Algorithm Interpretations Using Prototype mHealth Tympanometer

  Tympanogram results collected using the prototype mHealth tympanometer will be run through the ML algorithm for classification into Type A/B/C. Agreement between the audiologist and the ML algorithm with respect to the classification categories will be assessed.

  Same day as participant visit, up to 10 minutes

Study Arms (1)

Tympanometer Comparison

EXPERIMENTAL

Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer

Device: Prototype mHealth tympanometer; Device: Standard of care commercial tympanometer

Interventions

Prototype mHealth tympanometer DEVICE

The prototype mHealth tympanometer functions similarly to a commercial tympanometer. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C.

Tympanometer Comparison

Standard of care commercial tympanometer DEVICE

A commercial tympanometer routinely used as part of standard of care will be used as the comparison. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C.

Tympanometer Comparison

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting to Audiology Clinic for evaluation, where tympanometry is warranted for testing at the discretion of the audiologist
• Presence of various middle ear health states/pathologies that result in Type A, B, C tympanograms
• English-speaking

You may not qualify if:

• Children or adults with cognitive disabilities
• Unable to provide consent/assent
• Individuals who are unable to sit still
• Any other condition that in the opinion of the investigator, might interfere with the safe conduct of the study or place the participant at increased risk

Sponsors & Collaborators

• University of Arkansas: lead

MeSH Terms

Conditions

Hearing Loss; Otitis Media

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otitis

Results Point of Contact

• Title: Samantha Kleindienst Robler, AuD, PhD
• Organization: University of Arkansas for Medical Sciences

skrobler@uams.edu

9074340433

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be first tested with prototype mHealth tympanometer, and then with a commercial tympanometer routinely used in clinical settings.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 27, 2022
• Study Start: October 30, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2026-01